Novel Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor: University of Colorado, Denver
Study ID: NCT07759921
Status: Not Yet Recruiting

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Conditions

Colorectal Cancer
Metastatic Colorectal Cancer (CRC)

Eligibility Criteria

Sex: ALL
Age: 18 Years - 85 Years
Healthy Volunteers: Accepted

Interventions

Couple-based Mindfulness Intervention — BEHAVIORAL
Mindful PaCT is a manualized, couple-based mindfulness intervention designed to reduce distress and strengthen coping among patients with metastatic colorectal cancer and their partners. The intervention includes four weekly, 60- to 75-minute sessions delivered to each patient-partner dyad via secure videoconferencing by a trained interventionist. Sessions address four core mindfulness competencies: awareness, acceptance, compassion, and connection. Intervention content includes mindfulness-based education, guided experiential exercises, and skill-building activities designed to support individual and relational coping and adjustment in the context of advanced cancer. Couples receive a workbook containing session materials and access to supplemental audio and video recordings of guided mindfulness practices to support between-session practice and continued skill development.
Health and Wellness Education Control Condition — BEHAVIORAL
Wellness PaCT is a manualized, couple-based educational intervention designed as an active, attention-matched control condition for patients with metastatic colorectal cancer and their partners. The intervention includes four weekly, 60- to 75-minute sessions delivered to each patient-partner dyad via secure videoconferencing by a trained interventionist. Each session focuses on a wellness topic relevant to coping with metastatic colorectal cancer: general wellness, sleep and fatigue, diet and nutrition, and exercise and physical activity. Intervention content includes health education and structured activities intended to support healthy lifestyle behaviors in the context of advanced cancer. Couples receive a workbook containing session materials and access to supplemental educational resources to support continued learning between sessions.

Study Details

The overall objective of this study is to learn whether a newly developed couple-based mindfulness program (Mindful PaCT) is practical to complete (feasible), helpful and well-received (acceptable), and relevant for patients with metastatic colorectal cancer (mCRC) and their partners.

Key Dates

First listed: Aug 12, 2026
Start date: Dec 31, 2026
Status verified: Aug 2026
Primary completion: Dec 31, 2030
Completion: Dec 31, 2030

Study Design

Enrollment: 90 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Arms

Experimental: Mindful PaCT
Patient-partner dyads assigned to this arm receive Mindful PaCT, a couple-based mindfulness program delivered through four weekly, 60- to 75-minute sessions via secure videoconferencing. Sessions are facilitated by a trained interventionist. Couples also receive a program workbook and access to supplemental audio and video mindfulness practices for use between sessions.
Placebo Comparator: Wellness PACT
Patient-partner dyads assigned to this arm receive Wellness PaCT, a couple-based educational program delivered through four weekly, 60- to 75-minute sessions via secure videoconferencing. Sessions are facilitated by a trained interventionist and address general wellness, sleep and fatigue, diet and nutrition, and exercise and physical activity. Couples also receive a program workbook and supplemental educational resources for use between sessions.